New Animal Drugs; Changes of Sponsor, 17595-17598 [2013-06126]
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Federal Register / Vol. 78, No. 56 / Friday, March 22, 2013 / Rules and Regulations
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529,
and 558
[Docket No. FDA–2013–N–0002]
New Animal Drugs; Changes of
Sponsor
AGENCY:
Food and Drug Administration,
HHS.
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for 21 approved new
animal drug applications (NADAs) and
43 approved abbreviated new animal
drug applications (ANADAs) from Teva
Animal Health, Inc., to Bayer
HealthCare LLC.
DATES: This rule is effective March 22,
2013.
FOR FURTHER INFORMATION CONTACT:
Steven D. Vaughn, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7520 Standish Pl.,
Rockville, MD 20855; 240–276–8300;
email: steven.vaughn@fda.hhs.gov.
Teva
Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503 has
informed FDA that it has transferred
ownership of, and all rights and interest
in, the following 21 approved NADAs
and 43 approved ANADAs to Bayer
HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee
Mission, KS 66201:
SUPPLEMENTARY INFORMATION:
TABLE 1—APPLICATIONS TRANSFERRED
pmangrum on DSK3VPTVN1PROD with RULES
Application No.
Trade name
6–391 ..................................................................
6–677 ..................................................................
7–087 ..................................................................
33–157 ................................................................
40–040 ................................................................
45–416 ................................................................
48–287 ................................................................
55–002 ................................................................
65–110 ................................................................
65–498 ................................................................
91–818 ................................................................
93–483 ................................................................
94–170 ................................................................
99–169 ................................................................
119–142 ..............................................................
123–815 ..............................................................
124–241 ..............................................................
128–089 ..............................................................
140–270 ..............................................................
141–070 ..............................................................
141–245 ..............................................................
200–042 ..............................................................
200–068 ..............................................................
200–069 ..............................................................
200–108 ..............................................................
200–118 ..............................................................
200–123 ..............................................................
200–124 ..............................................................
200–126 ..............................................................
200–137 ..............................................................
200–147 ..............................................................
200–153 ..............................................................
200–162 ..............................................................
200–174 ..............................................................
200–177 ..............................................................
200–178 ..............................................................
200–181 ..............................................................
200–192 ..............................................................
200–193 ..............................................................
200–202 ..............................................................
200–219 ..............................................................
200–228 ..............................................................
200–230 ..............................................................
200–246 ..............................................................
200–248 ..............................................................
200–253 ..............................................................
200–254 ..............................................................
200–256 ..............................................................
200–265 ..............................................................
200–286 ..............................................................
200–287 ..............................................................
200–293 ..............................................................
200–297 ..............................................................
200–298 ..............................................................
200–319 ..............................................................
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S.Q. (sulfaquinoxaline) 40% Type A Medicated Article.
S.Q. (sulfaquinoxaline) 20% Solution.
Sulfaquinoxaline Solubilized.
SPECTAM (spectinomycin) Scour Halt.
SPECTAM (spectinomycin) Injectable Solution.
TEVCODYNE (phenylbutazone) Injectable Solution.
Oxytetracycline-50 Injectable Solution.
TEVCOCIN (chloramphenicol) Injection.
PEN–G–MAX (penicillin G procaine) Injectable Suspension.
DUAL–CILLIN (penicillin G benzathine and penicillin G procaine).
Phenylbutazone Tablets, USP 1 gram.
SPECTAM (spectinomycin) Injectable Solution.
Phenylbutazone Tablets, USP 100 or 200 mg.
Oxytocin Injection.
PVL Iron Dextran Injectable (iron hydrogenated dextran injection).
Dexamethasone Sodium Phosphate Injection.
PVL (oxytocin) Injectable.
ZONOMETH (dexamethasone) Solution.
SULFASURE (sulfamethazine) SR Cattle Bolus.
RAPINOVET (propofol) Injectable Emulsion.
TRIBUTAME (embutramide, chloroquine, and lidocaine) Euthanasia Solution.
Ketamine Hydrochloride Injection, USP.
Oxytetracycline Hydrochloride Injection 100.
FERTELIN (gonadorelin diacetate tetrahydrate) Injection.
Dexamethasone Solution.
Neomycin Oral Solution.
MAXIM–200 (oxytetracycline hydrochloride) Injection.
Flunixin Meglumine Injection.
Phenylbutazone 20% Injection.
Gentamicin Sulfate Solution (IU).
Gentamicin Sulfate Injection.
NEO 200 (neomycin sulfate) Oral Solution.
Tripelennamine Hydrochloride Injection.
Gentamicin Sulfate Pig Pump Oral Solution.
Sulfadimethoxine Injection 40%.
Amikacin Sulfate Injection.
Amikacin Sulfate Solution.
Sulfadimethoxine 12.5% Oral Solution.
Clindamycin Hydrochloride Oral Liquid.
PHOENECTIN (ivermectin) Oral Solution.
Ivermectin Pour-On for Cattle.
PHOENECTIN (ivermectin) Injectable Solution.
Guaifenesin Injection.
Pyrantel Pamoate Oral Suspension (OTC and Rx).
Pyrantel Pamoate Oral Suspension.
PROSTAMATE (dinoprost tromethamine) Injectable Solution.
Iron Dextran Injection—100.
Iron Dextran Injection—200.
Praziquantel Tablets (OTC and Rx).
PHOENECTIN (ivermectin) Paste 1.87%.
GBC (gentamicin sulfate, betamethasone valerate, and clotrimazole) Ointment.
Furosemide Injection 5%.
Ivermectin Chewable Tablets.
Clindamycin Hydrochloride Capsules.
Acepromazine Maleate Injection.
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17595
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17596
Federal Register / Vol. 78, No. 56 / Friday, March 22, 2013 / Rules and Regulations
TABLE 1—APPLICATIONS TRANSFERRED—Continued
Application No.
200–322
200–342
200–351
200–360
200–365
200–382
200–389
200–408
200–463
Trade name
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
..............................................................
Accordingly, the Agency is amending
the regulations in 21 CFR parts 510, 520,
522, 524, 529, and 558 to reflect these
transfers of ownership. Following these
changes of sponsorship, Teva Animal
Health, Inc., is no longer the sponsor of
an approved application. As such, 21
CFR 510.600 is being amended to
remove the entries for this firm.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
Butorphanol Tartrate Injection.
Pyrantel Pamoate Paste.
Lincomycin Injectable, USP.
TIAGARD (tiamulin) Liquid Concentrate.
ROBINUL–V (glycopyrrolate) Injectable.
Furosemide Syrup 1%.
Amprolium 9.6% Oral Solution.
Butorphanol Tartrate Injection.
Amprolium-P 9.6% Oral Solution.
Authority: 21 U.S.C. 360b.
§ 520.100
§ 520.1870
[Amended]
§ 520.2043
§ 520.446
■
[Amended]
15. In paragraph (b)(1) of § 520.2043,
remove ‘‘000069, 058829, and 059130’’
and in its place add ’’ 000069, 000859,
and 058829’’.
§ 520.447
§ 520.2044
[Amended]
6. In paragraph (b) of § 520.447,
remove ‘‘000009, 051311, 058829, and
059130’’ and in its place add ‘‘000009,
000859, 051311, and 058829’’.
■
16. In paragraph (b)(2) of § 520.2044,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
§ 520.2123c
[Amended]
[Amended]
■
[Amended]
17. In paragraph (b) of § 520.2123c,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
7. In paragraph (b)(3) of § 520.1010,
remove ‘‘058829 and 059130’’ and in its
place add ‘‘000859 and 058829’’.
■
§ 520.1044b
§ 520.2220a
[Amended]
8. In paragraph (b) of § 520.1044b,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
§ 520.1192
[Amended]
9. In paragraph (b)(2) of § 520.1192,
remove ‘‘051311, 054925, 059130, and
061623’’ and in its place add ‘‘000859,
051311, 054925, and 061623’’.
[Amended]
18. In paragraph (a)(1) of § 520.2220a,
remove ‘‘000010, 000069, 054925,
057561, and 059130’’ and in its place
add ‘‘000010, 000069, 000859, 054925,
and 057561’’.
■
■
§ 520.1193
[Amended]
PART 510—NEW ANIMAL DRUGS
10. In paragraph (b)(2) of § 520.1193,
remove ‘‘051311 and 059130’’ and in its
place add ‘‘000859 and 051311’’.
1. The authority citation for 21 CFR
part 510 continues to read as follows:
§ 520.1195
■
[Amended]
5. In paragraph (b)(1) of § 520.446,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
■
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 510, 520, 522, 524, 529, and
558 are amended as follows:
■
[Amended]
§ 520.2260b
[Amended]
19. In paragraph (f)(1) of § 520.2260b,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
§ 520.2325a
[Amended]
20. In paragraph (a)(1) of § 520.2325a,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
11. In paragraph (b)(1) of § 520.1195,
remove ‘‘050604, 054925, and 059130’’
and in its place add ‘‘000859, 050604,
and 054925’’.
■
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Teva Animal Health, Inc.’’; and in the
table in paragraph (c)(2), remove the
entry for ‘‘059130’’.
§ 520.1484
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
§ 520.1720a
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
§ 510.600
[Amended]
■
pmangrum on DSK3VPTVN1PROD with RULES
14. In paragraph (b)(2) of § 520.1870,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
4. In paragraph (b)(3) of § 520.100,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
§ 520.1010
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
[Amended]
3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
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[Amended]
12. In paragraph (b)(3) of § 520.1484,
remove ‘‘000009, 054925, 058005, and
059130’’ and in its place add ‘‘000009,
000859, 054925, and 058005’’.
■
[Amended]
13. In paragraph (b)(2) of § 520.1720a,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
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21. In § 520.2455, revise paragraph
(b)(2) and add paragraph (b)(3) to read
as follows:
§ 520.2455
Tiamulin.
*
*
*
*
(b) * * *
(2) No. 066104 for the product
described in paragraph (a)(1) of this
section.
(3) No. 000859 for the product
described in paragraph (a)(3) of this
section.
*
*
*
*
*
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Federal Register / Vol. 78, No. 56 / Friday, March 22, 2013 / Rules and Regulations
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
and 058005’’; and in paragraph (b)(7),
remove ‘‘042552 and 059130’’ and in its
place add ‘‘000859 and 042552’’.
22. The authority citation for 21 CFR
part 522 continues to read as follows:
§ 522.1192
■
34. In paragraph (b)(2) of § 522.1192,
remove ‘‘055529, 058005, 059130, and
061623’’ and in its place add ‘‘000859
055529, 058005, and 061623’’.
■
Authority: 21 U.S.C. 360b.
§ 522.23
[Amended]
23. In paragraph (b)(2) of § 522.23,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
§ 522.56
§ 522.1222a
[Amended]
35. In paragraph (b) of § 522.1222a,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
[Amended]
24. In paragraph (b) of § 522.56,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
§ 522.246
[Amended]
§ 522.1260
[Amended]
36. In paragraph (b)(2) of § 522.1260,
remove ‘‘058005 and 059130’’ and in its
place add ‘‘000859 and 058005’’.
■
[Amended]
25. In § 522.246, in paragraphs (b)(2)
and (b)(3), remove ‘‘059130’’ and in its
place add ‘‘000859’’.
■
§ 522.1660a
[Amended]
26. In paragraph (b) of § 522.390,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
37. In paragraph (b) of § 522.1660a,
remove ‘‘000010, 000069, 048164,
055529, 057561, 059130, and 061623’’
and in its place add ‘‘000010, 000069,
000859, 048164, 055529, 057561, and
061623’’.
§ 522.540
§ 522.1662a
§ 522.390
[Amended]
■
[Amended]
27. In § 522.540, in paragraphs
(a)(2)(i), (d)(2)(i), and (e)(2), remove
‘‘059130’’ and in its place add
‘‘000859’’; in paragraphs (b)(3)(i),
(b)(3)(ii), (c)(3)(i), and (c)(3)(ii), remove
the footnote reference ‘‘1’’; and remove
the text of footnote 1.
■
§ 522.810
[Amended]
28. In paragraph (b) of § 522.810,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
§ 522.1010
[Amended]
39. In paragraph (b) of § 522.1680,
remove ‘‘000010, 000856, 059130,
059130, and 061623’’ and in its place
add ‘‘000010, 000856, 000859, and
061623’’.
■
[Amended]
41. In § 520.1696b:
a. In paragraph (b)(1), remove
‘‘053501, 055529, and 059130’’ and in
its place add ‘‘000859, 053501, and
055529’’.
■ b. In paragraph (d)(2)(i)(A), remove
‘‘053501, 055529, 059130, and 061623’’
and in its place add ‘‘000859, 053501,
055529, and 061623’’.
■ c. In paragraph (d)(2)(iii)(B), remove
‘‘055529 and 059130’’ and in its place
add ‘‘000859 and 055529’’.
■
■
[Amended]
[Amended]
31. In paragraph (b) of § 522.1066,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
[Amended]
32. In paragraph (b) of § 522.1086,
remove ‘‘037990 and 059130’’ and in its
place add ‘‘000859 and 037990’’.
pmangrum on DSK3VPTVN1PROD with RULES
■
[Amended]
33. In § 522.1182, in paragraph (b)(1),
remove ‘‘042552 and 059130’’ and in its
place add ‘‘000859 and 042552’’; in
paragraph (b)(6), remove ‘‘058005 and
059130’’ and in its place add ‘‘000859
■
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15:13 Mar 21, 2013
Jkt 229001
44. In paragraph (b) of § 522.2120,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
§ 522.
2220 [Amended]
45. In paragraph (a)(2)(iii) of
§ 522.2220, remove ‘‘059130’’ and in its
place add ‘‘000859’’.
■
§ 522.2615
[Amended]
46. In paragraph (b) of § 522.2615,
remove ‘‘053501 and 059130’’ and in its
place add ‘‘000859 and 053501’’.
■
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
47. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 524.1044g
[Amended]
48. In paragraph (b)(3) of § 524.1044g,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
§ 524.1193
[Amended]
49. In paragraph (b)(2) of § 524.1193,
remove ‘‘054925, 059130, and 066916’’
and in its place add ‘‘000859, 054925,
and 066916’’.
■
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
50. The authority citation for 21 CFR
part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
§ 529.56
[Amended]
51. In paragraph (b) of § 529.56,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
§ 522.1696b
30. In paragraph (b)(4) of § 522.1044,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
§ 522.1182
[Amended]
■
[Amended]
40. In paragraph (b)(2) of § 522.1696a,
remove ‘‘055529, 059130, and 061623’’
and in its place add ‘‘000859, 055529,
and 061623’’.
■
§ 522.1086
§ 522.1680
■
[Amended]
29. In paragraph (b)(3) of § 522.1010,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
§ 522.1066
[Amended]
38. In paragraph (i)(2) of § 522.1662a,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
§ 522.1696a
■
§ 522.1044
■
§ 522.2120
17597
§ 522.1720
[Amended]
42. In paragraph (b)(1) of § 522.1720,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
§ 522.2005
43. In paragraph (b)(1) of § 522.2005,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
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Fmt 4700
Sfmt 4700
[Amended]
52. In paragraph (b) of § 529.1044a,
remove ‘‘000010, 000061, 000856,
057561, 058005, 059130, and 061623’’
and in its place add ‘‘000010, 000061,
000856, 000859, 057561, 058005, and
061623’’.
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
53. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
§ 558.586
[Amended]
■
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§ 529.1044a
[Amended]
54. In paragraph (b) of § 558.586,
remove ‘‘059130’’ and in its place add
‘‘000859’’.
■
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17598
Federal Register / Vol. 78, No. 56 / Friday, March 22, 2013 / Rules and Regulations
Dated: March 12, 2013.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2013–06126 Filed 3–21–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2013–0006]
Special Local Regulation; Southern
California Annual Marine Events for
the San Diego Captain of the Port Zone
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
pmangrum on DSK3VPTVN1PROD with RULES
ACTION:
SUMMARY: The Coast Guard will enforce
the 2013 San Diego Crew Classic Special
Local Regulation located in the
regulated area encompasses that portion
of Mission Bay, San Diego, California
bounded by Enchanted Cove, Fiesta
Island, Pacific Passage and DeAnza
Point, from 7 a.m. to 7 p.m. on April 6,
2013 and 7 a.m. to 7 p.m. on April 7,
2013. This action is necessary to
provide to provide for the safety of the
participants, crew, spectators, sponsor
vessels of the event, and general users
of the waterway. During the
enforcement period, no spectators shall
anchor, block, loiter in, or impede the
transit of participants or official patrol
vessels in the regulated area during the
effective dates and times, unless cleared
for such entry by Coast Guard Patrol
Commander or through an official
supporting vessel.
DATES: The regulations in 33 CFR
100.1101 will be enforced from 7 a.m.
to 7 p.m. on April 6, 2013 and 7 a.m.
to 7 p.m. on April 7, 2013.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice, call
or email Petty Officer Bryan Gollogly,
Waterways Management, U.S. Coast
Guard Sector San Diego, CA; telephone
619–278–7656, email D11-PFMarineEventsSanDiego@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the Special Local
Regulation for the 2013 San Diego Crew
Classic in 33 CFR 100.1101 from 7 a.m.
to 7 p.m. on April 6, 2013 and from 7
a.m. to 7 p.m. on April 7, 2013.
Under provisions of 33 CFR 100.1101,
a vessel may not enter the regulated
area, unless it receives permission from
the COTP. Spectator vessels may safely
transit outside the regulated area but
VerDate Mar<15>2010
15:13 Mar 21, 2013
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may not anchor, block, loiter, or impede
the transit of participants or official
patrol vessels. The Coast Guard may be
assisted by other Federal, State, or Local
law enforcement agencies in enforcing
this regulation.
This notice is issued under authority
of 33 CFR 100.1101 and 5 U.S.C. 552(a).
In addition to this notice in the Federal
Register, the Coast Guard will provide
the maritime community with extensive
advance notification of this enforcement
period via the Local Notice to Mariners.
If the Captain of the Port or his
designated representative determines
that the regulated area need not be
enforced for the full duration stated on
this notice, he or she may use a
Broadcast Notice to Mariners to grant
general permission to enter the
regulated area.
Dated: March 6, 2013.
S.M. Mahoney,
Captain, US Coast Guard, Captain of the Port
San Diego.
[FR Doc. 2013–06587 Filed 3–21–13; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF EDUCATION
34 CFR Parts 600, 602, 603, 668, 682,
685, 686, 690, and 691
[Docket ID ED–2010–OPE–0004]
RIN 1840–AD02
Program Integrity Issues
Office of Postsecondary
Education, Department of Education.
ACTION: Final regulations; revisions to
preamble.
AGENCY:
SUMMARY: On October 29, 2010, the
Department of Education published in
the Federal Register final regulations for
improving integrity in the programs
authorized under title IV of the Higher
Education Act of 1965, as amended
(HEA) (October 29, 2010, final
regulations). This document revises the
preamble discussion to the October 29,
2010, final regulations in accordance
with the remand in Association of
Private Sector Colleges and Universities
v. Duncan (D.C. Cir. 2012).
DATES: These revisions apply to the
preamble for the October 29, 2010,
regulations (75 FR 66832), which were
generally effective July 1, 2011.
FOR FURTHER INFORMATION CONTACT:
Marty Guthrie, U.S. Department of
Education, 1990 K Street NW., Room
8042, Washington, DC 20006.
Telephone: (202) 219–7031 or by email
at Marty.Guthrie@ed.gov.
If you use a telecommunications
device for the deaf (TDD), call the
PO 00000
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Federal Relay Service (FRS), toll free, at
1–800–877–8339.
Individuals with disabilities can
obtain this document in an accessible
format (e.g., braille, large print,
audiotape, or compact disc) by
contacting the contact person listed in
this section.
The
October 29, 2010, final regulations (75
FR 66832) amended the regulations for
Institutional Eligibility Under the HEA,
the Secretary’s Recognition of
Accrediting Agencies, the Secretary’s
Recognition Procedures for State
Agencies, the Student Assistance
General Provisions, the Federal Family
Education Loan (FFEL) Program, the
William D. Ford Federal Direct Loan
Program, the Teacher Education
Assistance for College and Higher
Education (TEACH) Grant Program, the
Federal Pell Grant Program, and the
Academic Competitiveness Grant (AGC)
and National Science and Mathematics
Access to Retain Talent Grant (National
Smart Grant) Programs. This document
revises the preamble discussion to the
October 29, 2010, final regulations in
accordance with the remand in
Association of Private Sector Colleges
and Universities v. Duncan, 681 F.3d
427 (D.C. Cir. 2012).
We note that the Court in APSCU v.
Duncan, also remanded certain
provisions of the Department’s
misrepresentation regulations for
revision consistent with the Court’s
opinion. We will be publishing a
separate notice in the Federal Register
addressing this issue.
SUPPLEMENTARY INFORMATION:
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is the document published in the
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E:\FR\FM\22MRR1.SGM
22MRR1
]]>Agencies
[Federal Register Volume 78, Number 56 (Friday, March 22, 2013)]
[Rules and Regulations]
[Pages 17595-17598]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06126]
[[Page 17595]]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529, and 558
[Docket No. FDA-2013-N-0002]
New Animal Drugs; Changes of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for 21 approved new
animal drug applications (NADAs) and 43 approved abbreviated new animal
drug applications (ANADAs) from Teva Animal Health, Inc., to Bayer
HealthCare LLC.
DATES: This rule is effective March 22, 2013.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855; 240-276-8300; email:
steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Teva Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503 has informed FDA that it has
transferred ownership of, and all rights and interest in, the following
21 approved NADAs and 43 approved ANADAs to Bayer HealthCare LLC,
Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201:
Table 1--Applications Transferred
------------------------------------------------------------------------
Application No. Trade name
------------------------------------------------------------------------
6-391........................ S.Q. (sulfaquinoxaline) 40% Type A
Medicated Article.
6-677........................ S.Q. (sulfaquinoxaline) 20% Solution.
7-087........................ Sulfaquinoxaline Solubilized.
33-157....................... SPECTAM (spectinomycin) Scour Halt.
40-040....................... SPECTAM (spectinomycin) Injectable
Solution.
45-416....................... TEVCODYNE (phenylbutazone) Injectable
Solution.
48-287....................... Oxytetracycline-50 Injectable Solution.
55-002....................... TEVCOCIN (chloramphenicol) Injection.
65-110....................... PEN-G-MAX (penicillin G procaine)
Injectable Suspension.
65-498....................... DUAL-CILLIN (penicillin G benzathine and
penicillin G procaine).
91-818....................... Phenylbutazone Tablets, USP 1 gram.
93-483....................... SPECTAM (spectinomycin) Injectable
Solution.
94-170....................... Phenylbutazone Tablets, USP 100 or 200
mg.
99-169....................... Oxytocin Injection.
119-142...................... PVL Iron Dextran Injectable (iron
hydrogenated dextran injection).
123-815...................... Dexamethasone Sodium Phosphate Injection.
124-241...................... PVL (oxytocin) Injectable.
128-089...................... ZONOMETH (dexamethasone) Solution.
140-270...................... SULFASURE (sulfamethazine) SR Cattle
Bolus.
141-070...................... RAPINOVET (propofol) Injectable Emulsion.
141-245...................... TRIBUTAME (embutramide, chloroquine, and
lidocaine) Euthanasia Solution.
200-042...................... Ketamine Hydrochloride Injection, USP.
200-068...................... Oxytetracycline Hydrochloride Injection
100.
200-069...................... FERTELIN (gonadorelin diacetate
tetrahydrate) Injection.
200-108...................... Dexamethasone Solution.
200-118...................... Neomycin Oral Solution.
200-123...................... MAXIM-200 (oxytetracycline hydrochloride)
Injection.
200-124...................... Flunixin Meglumine Injection.
200-126...................... Phenylbutazone 20% Injection.
200-137...................... Gentamicin Sulfate Solution (IU).
200-147...................... Gentamicin Sulfate Injection.
200-153...................... NEO 200 (neomycin sulfate) Oral Solution.
200-162...................... Tripelennamine Hydrochloride Injection.
200-174...................... Gentamicin Sulfate Pig Pump Oral
Solution.
200-177...................... Sulfadimethoxine Injection 40%.
200-178...................... Amikacin Sulfate Injection.
200-181...................... Amikacin Sulfate Solution.
200-192...................... Sulfadimethoxine 12.5% Oral Solution.
200-193...................... Clindamycin Hydrochloride Oral Liquid.
200-202...................... PHOENECTIN (ivermectin) Oral Solution.
200-219...................... Ivermectin Pour-On for Cattle.
200-228...................... PHOENECTIN (ivermectin) Injectable
Solution.
200-230...................... Guaifenesin Injection.
200-246...................... Pyrantel Pamoate Oral Suspension (OTC and
Rx).
200-248...................... Pyrantel Pamoate Oral Suspension.
200-253...................... PROSTAMATE (dinoprost tromethamine)
Injectable Solution.
200-254...................... Iron Dextran Injection--100.
200-256...................... Iron Dextran Injection--200.
200-265...................... Praziquantel Tablets (OTC and Rx).
200-286...................... PHOENECTIN (ivermectin) Paste 1.87%.
200-287...................... GBC (gentamicin sulfate, betamethasone
valerate, and clotrimazole) Ointment.
200-293...................... Furosemide Injection 5%.
200-297...................... Ivermectin Chewable Tablets.
200-298...................... Clindamycin Hydrochloride Capsules.
200-319...................... Acepromazine Maleate Injection.
[[Page 17596]]
200-322...................... Butorphanol Tartrate Injection.
200-342...................... Pyrantel Pamoate Paste.
200-351...................... Lincomycin Injectable, USP.
200-360...................... TIAGARD (tiamulin) Liquid Concentrate.
200-365...................... ROBINUL-V (glycopyrrolate) Injectable.
200-382...................... Furosemide Syrup 1%.
200-389...................... Amprolium 9.6% Oral Solution.
200-408...................... Butorphanol Tartrate Injection.
200-463...................... Amprolium-P 9.6% Oral Solution.
------------------------------------------------------------------------
Accordingly, the Agency is amending the regulations in 21 CFR parts
510, 520, 522, 524, 529, and 558 to reflect these transfers of
ownership. Following these changes of sponsorship, Teva Animal Health,
Inc., is no longer the sponsor of an approved application. As such, 21
CFR 510.600 is being amended to remove the entries for this firm.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, 522, 524, 529, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Sec. 510.600 [Amended]
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the entry
for ``Teva Animal Health, Inc.''; and in the table in paragraph (c)(2),
remove the entry for ``059130''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.100 [Amended]
0
4. In paragraph (b)(3) of Sec. 520.100, remove ``059130'' and in its
place add ``000859''.
Sec. 520.446 [Amended]
0
5. In paragraph (b)(1) of Sec. 520.446, remove ``059130'' and in its
place add ``000859''.
Sec. 520.447 [Amended]
0
6. In paragraph (b) of Sec. 520.447, remove ``000009, 051311, 058829,
and 059130'' and in its place add ``000009, 000859, 051311, and
058829''.
Sec. 520.1010 [Amended]
0
7. In paragraph (b)(3) of Sec. 520.1010, remove ``058829 and 059130''
and in its place add ``000859 and 058829''.
Sec. 520.1044b [Amended]
0
8. In paragraph (b) of Sec. 520.1044b, remove ``059130'' and in its
place add ``000859''.
Sec. 520.1192 [Amended]
0
9. In paragraph (b)(2) of Sec. 520.1192, remove ``051311, 054925,
059130, and 061623'' and in its place add ``000859, 051311, 054925, and
061623''.
Sec. 520.1193 [Amended]
0
10. In paragraph (b)(2) of Sec. 520.1193, remove ``051311 and 059130''
and in its place add ``000859 and 051311''.
Sec. 520.1195 [Amended]
0
11. In paragraph (b)(1) of Sec. 520.1195, remove ``050604, 054925, and
059130'' and in its place add ``000859, 050604, and 054925''.
Sec. 520.1484 [Amended]
0
12. In paragraph (b)(3) of Sec. 520.1484, remove ``000009, 054925,
058005, and 059130'' and in its place add ``000009, 000859, 054925, and
058005''.
Sec. 520.1720a [Amended]
0
13. In paragraph (b)(2) of Sec. 520.1720a, remove ``059130'' and in
its place add ``000859''.
Sec. 520.1870 [Amended]
0
14. In paragraph (b)(2) of Sec. 520.1870, remove ``059130'' and in its
place add ``000859''.
Sec. 520.2043 [Amended]
0
15. In paragraph (b)(1) of Sec. 520.2043, remove ``000069, 058829, and
059130'' and in its place add '' 000069, 000859, and 058829''.
Sec. 520.2044 [Amended]
0
16. In paragraph (b)(2) of Sec. 520.2044, remove ``059130'' and in its
place add ``000859''.
Sec. 520.2123c [Amended]
0
17. In paragraph (b) of Sec. 520.2123c, remove ``059130'' and in its
place add ``000859''.
Sec. 520.2220a [Amended]
0
18. In paragraph (a)(1) of Sec. 520.2220a, remove ``000010, 000069,
054925, 057561, and 059130'' and in its place add ``000010, 000069,
000859, 054925, and 057561''.
Sec. 520.2260b [Amended]
0
19. In paragraph (f)(1) of Sec. 520.2260b, remove ``059130'' and in
its place add ``000859''.
Sec. 520.2325a [Amended]
0
20. In paragraph (a)(1) of Sec. 520.2325a, remove ``059130'' and in
its place add ``000859''.
0
21. In Sec. 520.2455, revise paragraph (b)(2) and add paragraph (b)(3)
to read as follows:
Sec. 520.2455 Tiamulin.
* * * * *
(b) * * *
(2) No. 066104 for the product described in paragraph (a)(1) of
this section.
(3) No. 000859 for the product described in paragraph (a)(3) of
this section.
* * * * *
[[Page 17597]]
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
22. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.23 [Amended]
0
23. In paragraph (b)(2) of Sec. 522.23, remove ``059130'' and in its
place add ``000859''.
Sec. 522.56 [Amended]
0
24. In paragraph (b) of Sec. 522.56, remove ``059130'' and in its
place add ``000859''.
Sec. 522.246 [Amended]
0
25. In Sec. 522.246, in paragraphs (b)(2) and (b)(3), remove
``059130'' and in its place add ``000859''.
Sec. 522.390 [Amended]
0
26. In paragraph (b) of Sec. 522.390, remove ``059130'' and in its
place add ``000859''.
Sec. 522.540 [Amended]
0
27. In Sec. 522.540, in paragraphs (a)(2)(i), (d)(2)(i), and (e)(2),
remove ``059130'' and in its place add ``000859''; in paragraphs
(b)(3)(i), (b)(3)(ii), (c)(3)(i), and (c)(3)(ii), remove the footnote
reference ``1''; and remove the text of footnote 1.
Sec. 522.810 [Amended]
0
28. In paragraph (b) of Sec. 522.810, remove ``059130'' and in its
place add ``000859''.
Sec. 522.1010 [Amended]
0
29. In paragraph (b)(3) of Sec. 522.1010, remove ``059130'' and in its
place add ``000859''.
Sec. 522.1044 [Amended]
0
30. In paragraph (b)(4) of Sec. 522.1044, remove ``059130'' and in its
place add ``000859''.
Sec. 522.1066 [Amended]
0
31. In paragraph (b) of Sec. 522.1066, remove ``059130'' and in its
place add ``000859''.
Sec. 522.1086 [Amended]
0
32. In paragraph (b) of Sec. 522.1086, remove ``037990 and 059130''
and in its place add ``000859 and 037990''.
Sec. 522.1182 [Amended]
0
33. In Sec. 522.1182, in paragraph (b)(1), remove ``042552 and
059130'' and in its place add ``000859 and 042552''; in paragraph
(b)(6), remove ``058005 and 059130'' and in its place add ``000859 and
058005''; and in paragraph (b)(7), remove ``042552 and 059130'' and in
its place add ``000859 and 042552''.
Sec. 522.1192 [Amended]
0
34. In paragraph (b)(2) of Sec. 522.1192, remove ``055529, 058005,
059130, and 061623'' and in its place add ``000859 055529, 058005, and
061623''.
Sec. 522.1222a [Amended]
0
35. In paragraph (b) of Sec. 522.1222a, remove ``059130'' and in its
place add ``000859''.
Sec. 522.1260 [Amended]
0
36. In paragraph (b)(2) of Sec. 522.1260, remove ``058005 and 059130''
and in its place add ``000859 and 058005''.
Sec. 522.1660a [Amended]
0
37. In paragraph (b) of Sec. 522.1660a, remove ``000010, 000069,
048164, 055529, 057561, 059130, and 061623'' and in its place add
``000010, 000069, 000859, 048164, 055529, 057561, and 061623''.
Sec. 522.1662a [Amended]
0
38. In paragraph (i)(2) of Sec. 522.1662a, remove ``059130'' and in
its place add ``000859''.
Sec. 522.1680 [Amended]
0
39. In paragraph (b) of Sec. 522.1680, remove ``000010, 000856,
059130, 059130, and 061623'' and in its place add ``000010, 000856,
000859, and 061623''.
Sec. 522.1696a [Amended]
0
40. In paragraph (b)(2) of Sec. 522.1696a, remove ``055529, 059130,
and 061623'' and in its place add ``000859, 055529, and 061623''.
Sec. 522.1696b [Amended]
0
41. In Sec. 520.1696b:
0
a. In paragraph (b)(1), remove ``053501, 055529, and 059130'' and in
its place add ``000859, 053501, and 055529''.
0
b. In paragraph (d)(2)(i)(A), remove ``053501, 055529, 059130, and
061623'' and in its place add ``000859, 053501, 055529, and 061623''.
0
c. In paragraph (d)(2)(iii)(B), remove ``055529 and 059130'' and in its
place add ``000859 and 055529''.
Sec. 522.1720 [Amended]
0
42. In paragraph (b)(1) of Sec. 522.1720, remove ``059130'' and in its
place add ``000859''.
Sec. 522.2005 [Amended]
0
43. In paragraph (b)(1) of Sec. 522.2005, remove ``059130'' and in its
place add ``000859''.
Sec. 522.2120 [Amended]
0
44. In paragraph (b) of Sec. 522.2120, remove ``059130'' and in its
place add ``000859''.
Sec. 522. 2220 [Amended]
0
45. In paragraph (a)(2)(iii) of Sec. 522.2220, remove ``059130'' and
in its place add ``000859''.
Sec. 522.2615 [Amended]
0
46. In paragraph (b) of Sec. 522.2615, remove ``053501 and 059130''
and in its place add ``000859 and 053501''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
47. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1044g [Amended]
0
48. In paragraph (b)(3) of Sec. 524.1044g, remove ``059130'' and in
its place add ``000859''.
Sec. 524.1193 [Amended]
0
49. In paragraph (b)(2) of Sec. 524.1193, remove ``054925, 059130, and
066916'' and in its place add ``000859, 054925, and 066916''.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
50. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 529.56 [Amended]
0
51. In paragraph (b) of Sec. 529.56, remove ``059130'' and in its
place add ``000859''.
Sec. 529.1044a [Amended]
0
52. In paragraph (b) of Sec. 529.1044a, remove ``000010, 000061,
000856, 057561, 058005, 059130, and 061623'' and in its place add
``000010, 000061, 000856, 000859, 057561, 058005, and 061623''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
53. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.586 [Amended]
0
54. In paragraph (b) of Sec. 558.586, remove ``059130'' and in its
place add ``000859''.
[[Page 17598]]
Dated: March 12, 2013.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2013-06126 Filed 3-21-13; 8:45 am]
BILLING CODE 4160-01-P
